Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05563220
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2022-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
Sponsor:
Stemline Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELEVATE
Brief Summary:
This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.
Detailed Description:
This is a multicenter, Phase 1b/2 trial. The Phase 1b aims at selecting the RP2D dose, defined as a dose that is associated with less than 33% of participants experiencing a dose-limiting toxicity (DLT) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, ribociclib, and capivasertib that is, ≤1 participant experiencing a DLT out of 6 DLT-evaluable participants. For each combination, this phase will have approximately 3 cohorts of up to 6 DLT-evaluable participants each. The total number of DLT-evaluable participants in all the combinations will be up to 125.
The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.
The treatment arms will be:
* Arm A: 50 participants: elacestrant with alpelisib;
* Arm B: 50 participants: elacestrant with everolimus;
* Arm C: 60 participants (30 participants in each combination): elacestrant with either abemaciclib or ribociclib;
* Arm D: 90 participants (30 participants in each combination): elacestrant with either palbociclib, abemaciclib, or ribociclib;
* Arm E: 60 participants: elacestrant with capivasertib
Phase 1b will have a total of 125 participants, while Phase 2 will have 310 participants for all treatment arm combinations.
The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.
The treatment arms will be:
* Arm A: 50 participants: elacestrant with alpelisib;
* Arm B: 50 participants: elacestrant with everolimus;
* Arm C: 60 participants (30 participants in each combination): elacestrant with either abemaciclib or ribociclib;
* Arm D: 90 participants (30 participants in each combination): elacestrant with either palbociclib, abemaciclib, or ribociclib;
* Arm E: 60 participants: elacestrant with capivasertib
Phase 1b will have a total of 125 participants, while Phase 2 will have 310 participants for all treatment arm combinations.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: